Model-Based Risk Assessment of mAb Developability

M. Karlberg, A. Kizhedath and J. Glassey ()
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M. Karlberg: Newcastle University
A. Kizhedath: Newcastle University
J. Glassey: Newcastle University

A chapter in Optimization of Pharmaceutical Processes, 2022, pp 373-391 from Springer

Abstract: Abstract Monoclonal antibodies were already one of the fastest growing sectors of biopharmaceutical industry [1]. Recent research on the significant benefits of various antibodies in reducing the risks of fatality or reducing the symptoms of COVID-19, e.g., tocilizumab and sarilumab (Cortegiani et al. 2021), inevitably increases the importance of the rapid discovery of mAbs and the development of efficient manufacturing processes. Research reports frequently concentrated on the rapid discovery of new mAbs, but the developability and the manufacturability of mAbs were less explored until recently [1–4]. This chapter adopts the framework of quality by design (QbD), concentrating particularly on the model-based risk assessment of mAb developability. A case study highlights specific areas where advanced modelling approaches can contribute to speeding up the manufacturability and developability of mAbs and demonstrates the benefits and the challenges of this approach.

Date: 2022
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Persistent link: https://EconPapers.repec.org/RePEc:spr:spochp:978-3-030-90924-6_14

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DOI: 10.1007/978-3-030-90924-6_14

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